A Controlled Study to Evaluate the Efficacy and the Tolerability of a Cosmetic Active Ingredient Intended for Subjects With Atopic Dermatitis

Mild to Moderate Atopic Dermatitis Clinical Trial

Official title:

Randomized, Double Blind, Clinical Study for Evaluating the Efficacy and the Tolerability of a Cosmetic Active Ingredient Intended for Subjects With Atopic Dermatitis. Controlled Study vs Placebo

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05057351
• Other study ID #: H.E.HU.AD.NSO05.066.05.00
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: March 31, 2021

Study information

• Verified date: September 2021
• Source: Greenpharma S.A.S.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluation of safety and clinical efficacy of an active ingredient versus placebo for the treatment of mild to moderate Atopic Dermatitis (AD) adults.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 31, 2021
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Main Inclusion Criteria:

• Good general health

• Phototype I to IV

• Mild to moderate SCORAD (between 15 and 25)

Main Exclusion Criteria:

• Pregnant/breastfeeding female or who have planned a pregnancy during the study period

• Positive history for atopy or hypersensitive skin

• Subjects under systemically pharmacological treatment

• Subjects under locally pharmacological treatment on the skin area monitored during the test

• Subjects with congenital or acquired immunodeficiency

• Subjects under treatment with food supplements which could interfere with the functionality of the product under study

• Subjects which show other skin alterations on the monitored area except for acne lesions

• Subjects with known or suspected sensitization to one or more test formulation ingredients

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema
• Mild to Moderate Atopic Dermatitis

Intervention

Other:
• Isopentenyltheophylline 0.44% + Glycerin 4.56%
Application of topical cream twice a day on the area affected by Atopic Dermatitis
• Glycerin 4.56%
Application of topical cream twice a day on the area affected by Atopic Dermatitis

Locations

Country	Name	City	State
Italy	Complife Italia S.r.l.	San Martino Siccomario

Sponsors (2)

Lead Sponsor	Collaborator
Greenpharma S.A.S.	Complife Italia S.r.l

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in severity of Atopic Dermatitis as assessed using the SCORing Atopic Dermatitis (SCORAD)		7, 14 and 28 days